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NY Law Chief Sues Actavis to Block Namenda Forced Switch

[ Price : $8.95]

New York attorney general Eric T. Schneiderman files an antitrust lawsuit seeking to block Actavis and subsidiary Forest Laborator...

Guidance on ANDA Refuse to Receive Due to Impurity Deficiencies

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CDER posts a draft guidance on ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits that highli...

84% Say CDRH Delivering Good Customer Service

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An ongoing CDRH customer survey finds that 84% of respondents are satisfied with the Centers customer service.

FDA Finds Problems with Manufacturing Records at Sun Plant: Report

[ Price : $8.95]

FDA inspectors reportedly collect incomplete records during a surprise inspection that began earlier this month at Sun Pharmas Hal...

Inspection Finds QS Issues at Health Science Products

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FDAs New Orleans District Office warns Health Science Products about repeat Quality System and Medical Device Reporting regulation...

FDA Approves Movantik for Opioid-induced Constipation

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FDA approves an AstraZeneca NDA for Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic...

FDA Corrects Notice on Lot Distribution Report Guidance

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Federal Register Notice: FDA corrects a notice on a draft guidance on electronic submission of lot distribution reports.

QS, MDR Problems Found at Advanced MicroVas

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FDAs Dallas District Office warns Advanced MicroVas of quality system, medical device reporting, and other regulation violations i...

Court Rules for Catheter Connections in Patent Case

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The Utah federal district court says Ivera Medical violated a preliminary injunction barring it from selling Curos Tips that infri...

ANDA Refuse-to-Receive Standards Guidance

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FDA issues a guidance to help applicants submitting ANDAs to understand what deficiencies may lead the agency to refuse to receive...